Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) (PFAPA)
Periodic Fever, Aphthous Stomatitis, Pharyngitis
About this trial
This is an interventional treatment trial for Periodic Fever focused on measuring PFAPA
Eligibility Criteria
Inclusion Criteria:
- diagnosis or confirmation of diagnosis of PFAPA from Dr. Bennett based on clinical or laboratory data
- is or will be undergoing treatment for PFAPA at CCMC
- agrees to the consent and, if necessary, assent forms
- is between 1 and 12 years of age
Exclusion Criteria:
- is currently taking another probiotic regularly (>=2 times/ week)
- is allergic to ingredients in the probiotic or placebo
- may react adversely to the probiotic due to any form of immune deficiency or chronic disease including pulmonary, renal, cardiac disorders including underlying structural heart disease, gastrointestinal disease, or diabetes
- is not a proficient English speaker
- does not agree to the consent and/or assent forms
- patients who use antibiotics or have used them within a month of the study start
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Corticosteriod + Probiotic Treatment
Corticosteriod + PlaceboTreatment
Corticosteroid dosing of 1 mg/kg of body weight given once at the onset of the febrile period, repeated once within 24 hours if necessary, but no more than two doses per cycle. The second dose of corticosteroid treatment is only to be given within one day following the initial dosage if the fever persists. Investigational drug (Intervention is Lactobacillus acidophilus and Bifidobacterium lactis): Patients will be instructed to take one sachet of the study product mixed into a 60 ml of water that is not hot. Each sachet will contain Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 at a dose of 5*109 CFU of each strain. The investigational product will be taken daily for the duration of the study, which is a year.
Corticosteroid dosing of 1 mg/kg of body weight given once at the onset of the febrile period, repeated once within 24 hours if necessary, but no more than two doses per cycle. The second dose of corticosteroid treatment is only to be given within one day following the initial dosage if the fever persists. Placebo: will be taken daily and patients will be instructed to take one sachet of placebo mix into 60ml of water that is not to hot. The placebo will be taken daily for the duration of the study, which is one year. Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.